The present invention relates to drink mix compositions useful for reducing serum cholesterol levels comprising psyllium husk, an anion exchange resin, and edible, water soluble salts. The salt provides the benefit of reducing the gellation rate of the drink mix compositions when dispersed in an aqueous solution. Preferred salts are neutral in flavor such that the drink mix composition is perceived by the consumer as being "unflavored".
High blood cholesterol levels are associated with life threatening cardiovascular diseases. Cholestyramine and colestipol are drugs used in treating hypercholesterolemia. These drugs are known as basic anion exchange resins. They help to lower blood cholesterol levels apparently by binding to bile acids in the intestine. It is believed that this in turn causes an increase in hepatic metabolism of cholesterol to replenish the bile acids lost to complexation with the anion exchange resins.
Cholestyramine is usually dosed at four grams, one to six times daily. At the present time cholestyramine is commercially available as Questran.RTM. and Questran.RTM. Light (manufactured by the Bristol-Myers Company) in a four gram unit dose powder packet or in bulk powder, and as Cholybar.RTM. (manufactured by Parke Davis) wherein one chewable bar contains four grams of cholestyramine. [Physicians Desk Reference, 46th Edition, pages 710-712 and 1705-1706 (1992).]
Colestipol is usually administered at five to thirty grams daily given once or in divided doses. Colestipol is commercially available under the tradename Colestid.RTM. (colestipol hydrochloride granules, manufactured by The Upjohn Company). It is sold in a five gram unit dose powder packet or in bulk powder. [Physicians Desk Reference, 46th Edition, pages 2328-2329 (1992)].
Recent research has demonstrated that psyllium seed husk fiber is also effective in reducing human serum cholesterol levels. In addition, psyllium seed husk fiber has been found to be effective in controlling blood glucose levels in diabetics and in providing laxation and normalization of bowel function. Products containing psyllium seed husk are known (for example, Metamucil.RTM., sold by The Procter & Gamble Company).
Drink mix compositions containing psyllium husk and an anion exchange resin begin to gel once dispersed in an aqueous solution with an accompanying increase in the viscosity of the drink solution. The gellation rate is further increased relative to psyllium alone, believed to be due to ionic interaction of the anionic psyllium husk with the polycationic anion exchange resin in the aqueous solution. The consumer of such drink mix suspension must drink the liquid suspension in a relatively short period of time (less than about two minutes) in order to avoid having to drink an aesthetically unacceptable high viscosity liquid. After this time period the solution is likely to be considered too thick to enjoy drinking or too difficult to drink.
One possible way to control the rate of gellation is by using acids to reduce the pH of the drink mix solution. However, typical acids can impart too strong a flavor (e.g., a sour or bitter flavor) to the solution. This is especially a concern at higher acid levels which may be desired to maximize the reduction in gellation rate. In addition, the acids must be consistent with the flavor system being used in the composition. Obviously, a highly acidic medium is not suitable for flavor systems which require neutral or basic conditions. Also, except in certain controlled circumstances, acids are not suited for use in unflavored systems.
For these reasons, there continues to be a need for psyllium/anion exchange resin-containing drink mix compositions having reduced (slower) gellation rates. It has been discovered by the present invention that the gellation rate of such drink mix compositions in an aqueous solution can be slowed by adding a sufficient amount of an edible, water soluble salt. This discovery is useful, for example, for allowing the use of less acid or no acid (to reduce or eliminate the acid characteristic of drink compositions), to permit a wider variety of flavor systems (including "unflavored" versions of such drink mix compositions), and to further reduce the gellation rate for compositions containing higher levels of acid.
It is therefore an object of the present invention to provide improved drink mix compositions containing psyllium and an anion exchange resin (e.g., cholestyramine) having reduced gellation rates in aqueous solution and/or improved aesthetics. It is also an object to provide such drink mix compositions which are unflavored or are not highly acidic flavored systems.
These and other objects of the present invention will become readily apparent from the detailed description which follows.
All percentages and ratios used herein are by weight unless otherwise specified. Screen mesh sizes used herein are based on U.S. standards.